MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 340MM / RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.033.064S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Date of Event	04/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part number: 04.033.064s, synthes lot number: l945713, manufacturing site: (b)(4), release to warehouse date: july 05, 2018, expiry date: april 30, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, during a femoral recon nailing of 1/3 shaft fractured femur on the patient, the right titanium cannulated femoral recon nail was becoming incarcerated within the femoral shaft.The surgeon had to reamed up to 12mm for the insertion of the 10mm nail.Upon removal of the incarcerated nail, there was femoral neck fracture.After the removal of the 10mm nail, a 9mm nail was inserted, and the femoral neck fracture was reduced and fixated with 6.5 cannulated screws.The surgeon had to ream to 14.5mm in order to insert the 9mm nail.The surgeon complaint that the proximal portion of the nail was too wide in diameter, therefore resulting in the incarnation due to the long or wide proximal taper of the femoral recon nail.The medical intervention required since, they had to change tables to insert 6.5 cannulated screws into the femoral neck after the insertion of the 9mm nail and extra x-rays were needed.There was a surgical delay approximately of one hour and sixty (60) minutes.Procedure successfully completed.Patient status is good.Concomitant devices reported: unknown reamer (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM / TI CANN FRN / GT 340MM / RIGHT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10002256
• Report Number: 2939274-2020-02052
• Device Sequence Number: 13972498
• Product Code: HSB
• UDI-Device Identifier: 10886982271990
• UDI-Public: (01)10886982271990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.033.064S
• Device Catalogue Number: 04.033.064S
• Device Lot Number: L945713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/15/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM / TI CANN FRN / GT 340MM / RIGHT - STERILE; UNK - REAMERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR